The Digital Data Flow (DDF) initiative from TransCelerate BioPharma aims to move the drug development process from a current state of manual study startup asset creation (i.e., Case Report Forms, Procedure Manuals, Statistical Analysis Plans, and Schedule of Activities) to a future state of fully-automated, dynamic, study startup readiness. TransCelerate BioPharma is a non-profit collaborative organization within the pharmaceutical industry that was formed to "facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines". TransCelerate has worked on many initiatives and one of its key data-related projects is the DDF initiative to accelerate study start-up by leveraging a unified study definitions model and associated technical standards (API specifications). TransCelerate will build a reference implementation of a study definitions repository to showcase developed standards and demonstrate the connectivity made possible through these standards, between systems that produce study definitions data and systems that consume the data (e.g., EDC, CTMS).

Currently, many of the study build and data flow processes require significant manual effort that are expensive and costly, and lead to quality issues downstream. Under the DDF vision, many of these processes can be automated and done in parallel because a common data model is used to capture and reuse not only standards, but structured content from the protocol to drive efficiencies across the clinical development lifecycle, including study build automation across many different solutions and artifacts, such as data collection, randomization, and study data tabulations.